Kyowa Kirin is a finished-dose manufacturer based in Japan. It appears in 148 regulatory filings across 21 regulators, without an active US DMF or CEP on file. Its filings concentrate with SFDA (Saudi Arabia), Health Canada and MHRA (UK). Its GMP standing is certified by EMA and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 14 December 2022 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Hoofddorp, United Arab Emirates | Not on file |
| Genève, Switzerland | Not on file |
| GALASHIELS, United Kingdom | Not on file |
| TAKASAKI, Japan | Not on file |
| Japan, Japan | 3007588904 |
| Hoofddorp, Netherlands | Not on file |
1 further sites are on record.
| Regulator | Filings | GMP certificates |
|---|---|---|
| SFDA (Saudi Arabia) | 15 | None |
| Health Canada | 15 | None |
| MHRA (UK) | 14 | None |
| EMA | 13 | 2 |
| AIFA (IT) | 11 | None |
| NPRA (MY) | 11 | None |
| ANVISA (Brazil) | None | 1 |
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